A Study of ZL-1310 in Participants With Selected Solid Tumors

Launched by ZAI LAB (SHANGHAI) CO., LTD. · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ZL-1310 for adults with certain types of solid tumors, which are abnormal masses of tissue. The trial is in its early stages and aims to see how safe and effective this treatment is for patients who have already tried other therapies without success. To be eligible, participants need to be at least 18 years old, have a specific type of cancer that has progressed after initial treatment, and must be willing to provide a sample of their tumor for testing. They should also have a good level of health, being able to perform daily activities with little to no assistance.

If you join the trial, you will receive the study medication and may need to have some tests done, including a tumor biopsy, to monitor how you respond. It’s important to know that there are specific health conditions that may prevent someone from participating, such as other active cancers or certain recent treatments. The trial is currently not recruiting participants, but it’s a chance to contribute to research that could help improve cancer treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent
• • Adult men and women ≥18 years of age
• • Participants must have histologically confirmed, locally advanced or metastatic NECs, and must have experienced disease progression on or after platinum-based therapy
• • Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
• • Participants must have at least one measurable target lesion as defined by RECIST v1.1
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • Life expectancy ≥ 3 months
• Exclusion Criteria:
• • Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
• • Clinically active central nervous system (CNS) metastases
• • Participants with leptomeningeal metastasis
• • Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)
• • Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
• • Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or a history of radiation pneumonitis
• • Major surgery within 4 weeks of the first dose of study treatment
• • Hypersensitivity to any ingredient of the study treatment
• • Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
• • Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
• • Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
• • Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
• • Pregnant or nursing (lactating) women
• • Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer